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Results For "Biologics-License-Application"

80 News Found

Sanofi and IGM Biosciences team up to commercialise IgM antibody agonists
Biotech | March 30, 2022

Sanofi and IGM Biosciences team up to commercialise IgM antibody agonists

Companies to leverage proprietary IgM antibody technology platform to discover agonists against three oncology targets and three immunology/inflammation targets


USFDA approves EUA for second booster dose of Moderna
News | March 29, 2022

USFDA approves EUA for second booster dose of Moderna

50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age


Amneal enters U.S. biosimilars market with approval of Releukotm
Drug Approval | March 02, 2022

Amneal enters U.S. biosimilars market with approval of Releukotm

First of three Amneal biosimilars expected for U.S. approval and launch in 2022


Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review
Biotech | March 01, 2022

Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review

If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.


Daewoong Pharmaceutical posts strong financials in 2021
News | February 22, 2022

Daewoong Pharmaceutical posts strong financials in 2021

Daewoong delivered KRW 1.055 trillion in sales, KRW 95.5 billion in operating profit and KRW 40.5 billion in net profit.


USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi
Biotech | February 17, 2022

USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi

Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years


Lupin signs deal with Axantia to market pegfilgrastim in Middle East and Africa
News | February 01, 2022

Lupin signs deal with Axantia to market pegfilgrastim in Middle East and Africa

Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy


Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval
Biotech | February 01, 2022

Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval

Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel


Lannett receives USFDA safety review for biosimilar insulin glargine
Biotech | January 22, 2022

Lannett receives USFDA safety review for biosimilar insulin glargine

Go-ahead for pivotal clinical trial which is expected to commence by March


South Korea approves Novavax Covid-19 vaccine
Drug Approval | January 13, 2022

South Korea approves Novavax Covid-19 vaccine

Nuvaxovid is the first protein-based Covid-19 vaccine granted approval in South Korea